Abstract
The move toward electronic submission and review of new drug applications (NDAs) is expected to make the drug development process more efficient both for drug spon sors and the Food and Drug Administration (FDA). Electronic tools have been devel oped for text management, image management, and data manipulation, increasing the efficiency of FDA review and enabling pharmaceutical companies to bring new drugs to market quicker. This paper focuses on tools used to access, retrieve, and display information in the NDA submission, concentrating mainly on the text and image portions. It will conclude with a description of an "ideal" computer-assisted new drug application (CANDA) system and how it could be used by both the drug sponsor and the regulatory reviewer.
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